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This study compares two anesthesia medicines to see how well a brain monitor shows how deeply a patient is asleep during abdomen surgery

Correlation of Bispectral Index with Depth of Sedation: A Comparison Between Dexmedetomidine and Propofol in Patients Undergoing Abdominal Surgery Under General Anesthesia - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102986
Enrollment
60
Registered
2026-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified

Interventions

Intervention1: Dexmeditomidine: Dexmedetomidine will be administered intravenously. A loading dose of 1 g/kg will be given over 10 minutes, followed by a continuous intravenous infusion at a rate of

Sponsors

Saptagiri Mypati
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged eighteen to sixty five years of either gender belonging to ASA physical status one or two scheduled for elective abdominal surgery under general anesthesia and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with neurological disorders affecting electroencephalogram, chronic use of sedatives or opioids, severe cardiac hepatic or renal disease, known allergy to study drugs, pregnant or lactating women and patients unwilling to participate.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the correlation between Bispectral Index (BIS) values and clinical depth of sedation assessed using the Ramsay Sedation Scale (RSS) in patients receiving dexmedetomidine or propofol during abdominal surgery under general anesthesia. This primary outcome is used to assess the effect of the intervention and comparator agents on depth of sedation and forms the basis for comparison between the two groups.Timepoint: *Baseline (before induction of anesthesia) *Post-induction *At skin incision *Every 5 minutes intraoperatively *At the end of surgery

Secondary

MeasureTime frame
Comparison of bispectral index values between dexmedetomidine and propofol groups.Timepoint: Intraoperative period.;Hemodynamic parameters including heart rate and blood pressure.Timepoint: Baseline, intraoperative period and end of surgery.;Recovery profile including time to eye opening extubation and orientation.Timepoint: Postoperative period.;Incidence of adverse events related to study drugs.Timepoint: Intraoperative and postoperative period.

Countries

India

Contacts

Public ContactSaptagiri Mypati

Vinayaka Missions Kirupananda Variyar Medical College & Hospital

sabapathyv.appavoo@gmail.com9442566989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026